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Completed

NCT Number: NCT02140151

Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration

This study will determine whether quarterly injections of Ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration (AMD).

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Key information

Conditions

Age-Related Macular Degeneration Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Carbohydrate Metabolism, Inborn Errors Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Glycogen Storage Disease Glycogen Storage Disease Type II Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Macular Degeneration Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Retinal Degeneration Retinal Diseases Wet Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Northern California Retina Vitreous Associates, Mountain View, California, United States

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About this study

This is a multicenter, prospectively randomized, masked and controlled, interventional investigator sponsored phase I/II study of subjects with high-risk nonexudative age-related macular degeneration (AMD) treated with intravitreal ranibizumab quarterly for prophylaxis of conversion to exudative age-related macular degeneration.

The objective of this study is to investigate the safety and efficacy of prophylactic anti-vascular endothelial growth factor (VEGF) therapy with ranibizumab to prevent the development of exudative AMD in eyes with high-risk nonexudative AMD. In addition, baseline characteristics of high-risk eyes (fundus features, optical coherence tomography (OCT) parameters and genetic profile) will be evaluated to determine their predictive value in conversion to exudative AMD. The effect of ranibizumab on the atrophic component of AMD will also be monitored.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult over 50 years old
  • Able to sign informed consent and comply with the study protocol for the duration of two years
  • Nonexudative age-related macular degeneration (AMD) in one eye (study eye)
  • History of exudative AMD in one eye only (fellow eye) diagnosed within 5 years of study enrollment

Exclusion criteria

  • Participation in another simultaneous medical investigation or clinical trial
  • Patient is pregnant, lactating, or premenopausal and not using adequate contraception
  • Known serious allergies to ranibizumab, fluorescein dye, drugs for pupillary dilation, topical anesthetic, sterilizing solution (e.g. Betadine solution)
  • Presence of ocular conditions with increased risk of choroidal neovascularization (CNVM) or pigment epithelial detachment (PED), including presumed ocular histoplasmosis syndrome (POHS), traumatic choroidal rupture, angioid streaks, pathologic myopia (spherical equivalent of ≥ -8 diopters or axial length of ≥ 25 mm), multifocal choroiditis, macular choroidal nevus, polypoidal choroidal vasculopathy (PCV), idiopathic central serous chorioretinopathy (ICSC), etc.
  • History of vitrectomy in the study eye
  • History of cataract surgery within 3 months of enrollment
  • History of yttrium aluminum garnet (YAG) capsulotomy within 1 month of enrollment
  • History of intraocular or periocular corticosteroid therapy within the past 90 days
  • History of therapeutic radiation in the region of the study eye.
  • Presence of media opacity that would preclude adequate examination and/or imaging
  • Concurrent macular conditions that would affect the study parameters (epiretinal membrane, macular hole, macular edema) or require treatment within the duration of the study
  • Any progressive ocular condition (uncontrolled glaucoma, diabetic retinopathy, uveitis) that may affect the visual acuity for the duration of the study
  • Active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at enrollment
  • Presence of any advanced systemic condition that may hinder the patients participation and completion of the study
  • Concurrent use of systemic anti-VEGF therapy

Treatment and study plan

Ranibizumab 0.5mg

Drug

Other names: Lucentis

Primary outcomes

  1. Development of exudative AMD

    Time frame: 2 years

    Development of choroidal neovascularization (conversion) defined by the presence of leakage on fluorescein angiography (FA) and fluid within or below the retina or below the retinal pigment epithelium seen on spectral-domain optical coherence tomography (SD-OCT)

Secondary outcomes

  1. Vision change

    Time frame: 2 years

    Change in best-corrected visual acuity (BCVA) from baseline at 12 and 24 months

  2. Vision loss

    Time frame: 2 years

    Proportion of eyes losing < 5, 10, and 15 letters on EDTRS chart at 12 and 24 months

  3. Number of injections

    Time frame: 2 years

    Number of injections required in eyes that convert from dry to wet AMD during the study period

  4. Baseline predictive factors

    Time frame: 2 years

    Baseline demographic, genetic and ocular characteristics predictive of development of wet AMD

  5. Development of geographic atrophy (GA)

    Time frame: 2 years

    Development of geographic atrophy (GA) as detected by fundus photography (FP) and/or fundus autofluorescence (AF).

  6. Ocular adverse events

    Time frame: 2 years

    Incidence and severity of ocular adverse events, as identified by eye examination and imaging

  7. Systemic adverse events

    Time frame: 2 years

    Incidence and severity of other adverse events, as identified by physical examination or subject reporting.

Sponsors and collaborators

Lead sponsor

Southern California Desert Retina Consultants, MC

Other

Registry information

Official study title

Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration (AMD) in Vulnerable Eyes With Nonexudative AMD Trial: A Multicenter, Prospectively Randomized, Masked and Controlled, Interventional Investigator Sponsored Phase I/II Study

Acronym: PREVENT

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
May 16, 2014
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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